AzTrials
AzTrials

Metabolic SyndromeNCT01472666

Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth"

A study testing High content of MC-SFA, Whey and Low content of MC-SFA in people with Metabolic Syndrome and Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Dairy food contains a large amount of long-chain saturated fat, which traditionally has been linked to increased risk of cardiovascular disease (CVD). However, recent data indicates a more neutral role. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
High content of MC-SFA, Whey and Low content of MC-SFA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteDenmark
Study dates
Oct 2011to Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Metabolic syndrome
  • Central obesity (Waist: female ≥ 80 cm; male ≥ 94 cm)
  • with two or more of the following
  • Fasting triglyceride > 1.7 mmol/l
  • HDL-cholesterol; male < 1.03 mmol/l, female < 1.29 mmol/l
  • BP ≥ 130/85
  • Fasting plasma glucose ≥ 5,6 mmol/l (but not diabetes)
  • Or abdominal obesity (Waist: female ≥ 80 cm; male ≥ 94 cm)

Who cannot join

  • Significant cardiovascular, renal or endocrine disease
  • Psychiatric history
  • Treatment with steroids
  • Alcohol- or drug-addiction
  • Pregnancy or lactation

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Aarhus University Hospital

    Aarhus, Aarhus C, 8000

Other trials in Denmark

About this study

Dairy food contains a large amount of long-chain saturated fat, which traditionally has been linked to increased risk of cardiovascular disease (CVD). However, recent data indicates a more neutral role. Milk fat contains large amounts of medium-chain saturated fatty acids (MC-SFA), which may have beneficial effects on human health. In addition, milk proteins and in particular whey proteins have been shown to have a beneficial effect on glucose disposal as well as anti-inflammatory properties. Therefore dairy products have a potential role in the treatment of the metabolic abnormalities of metabolic syndrome (MeS). However, human data from intervention studies are lacking.

Aims of this project is to explore and understand the influence on human health of both medium-chain saturated fatty acids from milk fat and bioactive milk proteins per se as well as their interaction and potential positive synergy on the MeS.

Read more

The investigators hypothesize that whey protein and medium-chain saturated fatty acids improve insulin sensitivity, postprandial lipid metabolism, blood pressure and inflammatory stress in humans and that they possess preventive effects on the risk of developing CVD and type 2 diabetes mellitus (T2DM).

A total of 64 people with MeS or abdominal obesity will be included. The design is a randomized double-blinded, controlled parallel diet-intervention trial.

Subjects are assigned one of four experimental diets for 12 weeks. The diets consist of either a diet with low levels of MC-SFA + whey protein (LF + whey), a diet high in MC-SFA + whey protein (HF + whey), a diet high in MC-SFA + casein protein (HF + casein) or a diets with low levels of MC-SFA + casein protein (LF + casein). The subjects are advised how to integrate the test foods in their habitual diet, which also continues unchanged. The subjects' energy intake is matched so they are kept weight stable throughout the study.

Read the detailed description

See above.

Being tested
High content of MC-SFA, Whey, Low content of MC-SFA, Casein
Keywords
Medium chain fatty acids, Saturated fatty acids, Whey protein, Casein protein, Metabolic syndrome, Type 2 diabetes, Cardiovascular disease, Dairy products, Dietary intervention
Medical subject headings
Metabolic Syndrome, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Obesity, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High content of MC-SFADietary supplement

    12 weeks dietary intervention

  • WheyDietary supplement

    12 weeks dietary intervention

  • Low content of MC-SFADietary supplement

    12 weeks dietary intervention

  • CaseinDietary supplement

    12 weeks dietary intervention

Study groups in NCT01472666
Study groupRoleWhat they receive
Fat rich in MC-SFAExperimental63 gram milk fat with high content of MC-SFA (C6-C12=8.5 g) incorporated in rolls, muffin and as butter.
Receives: Dietary Supplement: High content of MC-SFA
Fat low on MC-SFAExperimental63 gram milkfat with low content of MC-SFA (C6-C12=6.9 g) incorporated in rolls, muffin and as butter
Receives: Dietary Supplement: Low content of MC-SFA
Casein proteinExperimental60 gram casein protein (Miprodan 30) ingested twice daily with 600 ml water.
Receives: Dietary Supplement: Casein
Whey proteinExperimental60 gram whey protein (Lacprodan DI-9224) ingested twice daily with 600 ml water.
Receives: Dietary Supplement: Whey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postprandial triglyceride response

    Compare the changes in mean difference of 6 hours incremental area under the curve (iAUC) (week 12 - week 0) between the groups and the intervention components.

    Measured: Change from week 0 to week 12

Secondary outcomes (11)

  1. 24 hour blood pressure (BP)

    Spacelabs, model 90207/90217, USA

    Measured: Change from week 0 to week 12

  2. Indirect calorimetry

    Measured 2 times during meal test.

    Measured: Change from week 0 to week 12

  3. Dexa-scan (body composition)

    Total body fat percentage, lean mass, gynoid, and android fat percentage, and total body weight.

    Measured: Change from week 0 to week 12

  4. Weight

    Measured: Change from week 0 to week 12

  5. Biomarkers in blood samples

    Glucose, insulin, glucagon, HbA1c. free fatty acids, Lipid profile (total-cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride). Inflammations markers (interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-1 receptor antagonist (IL-1RA), interleukin-1 beta (IL-1b), high sensitive c-reactive protein (hs-CRP), adiponectin, monocyte chemoattractant protein-1 (MCP-1), Rantes (CCL5)). Incretins (GLP-1, GIP). Nutrigenomics. Metabolomics. Proteomics.

    Measured: Change from week 0 to week 12

  6. Waist and hip circumference

    Measured: Change from week 0 to week 12

  7. Fat tissue biopsy

    Fat tissue gene expression. Twice during meal test.

    Measured: Change from week 0 to week 12

  8. Biomarkers in urine

    Nutrigenomics and metabolomics

    Measured: Change from week 0 to week 12

  9. Glucose tolerance

    Oral glucose tolerance test (OGTT) (with insulin and glucose measurement at time -15 min, -10 min, 0 min, 30 min, 60 min, and 120 min). Hereby calculating the homeostatic model assessment of insulin resistance (HOMA-IR) and the Matsuda index.

    Measured: Change from week 0 to week 12

  10. Dietary compliance

    3-day food diary.

    Measured: Change from week 0 to week 12

  11. Postprandial apolipoprotein-48 (apoB-48), 6 hour

    Meal test, blood samples at time 0,2,4 and 6 hours.

    Measured: Change from week 0 to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01472666
Sponsor's protocol ID
CERN-DairyHealth
Status last verified
Jul 2013
First submitted
1 Nov 2011
Last updated
1 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No: No plan to share data

Publications

  • Bohl M, Bjornshave A, Rasmussen KV, Schioldan AG, Amer B, Larsen MK, Dalsgaard TK, Holst JJ, Herrmann A, O'Neill S, O'Driscoll L, Afman L, Jensen E, Christensen MM, Gregersen S, Hermansen K. Dairy proteins, dairy lipids, and postprandial lipemia in persons with abdominal obesity (DairyHealth): a 12-wk, randomized, parallel-controlled, double-blinded, diet intervention study. Am J Clin Nutr. 2015 Apr;101(4):870-8. doi: 10.3945/ajcn.114.097923. Epub 2015 Jan 14.

    PubMed 25833983

Questions about this trial

What is this clinical trial studying?

A study testing High content of MC-SFA, Whey and Low content of MC-SFA in people with Metabolic Syndrome and Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postprandial triglyceride response (time frame: Change from week 0 to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01472666, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in